We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

• Provide strategic leadership for the PA Quality and Regulatory Affairs organizations in support of business objectives, ensuring alignment with corporate and business unit Quality and Regulatory Affairs strategies while enabling innovation and operational excellence.
• Serve as an active member of the PA Leadership Team and the Quality Leadership Team (QLT), contributing to enterprise quality strategy and decision‑making across regions and functions.
• Partner across business unit functions to design, deploy, and continuously improve innovative, effective, and compliant Quality processes, systems, and tools that accelerate new‑product commercialization and reduce time to market.
• Develop and implement global regulatory strategies aligned with corporate objectives.
• Monitor global regulatory trends and proactively adjust strategies to mitigate risks and capitalize on opportunities.
• Ensure timely responses to regulatory agencies and manage interactions with Notified Bodies and Competent Authorities worldwide.
• Maintain adherence to global regulatory requirements throughout the product lifecycle. Strong software and cybersecurity working knowledge.
• Lead internal audits and regulatory inspections; ensure readiness and successful outcomes.
• Partner with R&D, Clinical, and Marketing teams to integrate regulatory considerations into product development and commercialization plans.
• Lead the evolution of Quality functional work systems, methodologies, and capabilities, focusing on operational efficiency, scalability, and sustained competitive advantage.
• Drive Quality Excellence through end‑to‑end BD Excellence processes by developing the organizational capabilities, systems, and governance required to deliver consistent outcomes across engineering, manufacturing, and distribution.
• Lead the deployment of BD Excellence Lean principles, fostering a culture of daily management, continuous improvement, and Lean‑driven quality performance.
• Champion a prevention‑focused Quality culture by “bringing quality into daily view,” reinforcing accountability, and branding Quality as an enabler of innovation, productivity, and operational excellence.
• Ensure the Quality Management System effectively incorporates existing and emerging regulatory and customer requirements, translating regulatory expectations into practical, sustainable processes that are consistently implemented and maintained.
• Lead and oversee field action decision‑making, including risk assessment, regulatory impact evaluation, and cross‑functional alignment, to ensure timely, compliant, and effective resolution of product quality issues in partnership with Regulatory Affairs and Medical Affairs.
• In partnership with business leaders, own resourcing and execution of quality and compliance risk‑reduction initiatives, including robust CAPA and preventive action programs, remediation of legacy issues, and mitigation of emerging risks.
• Monitor, identify, and address significant quality issues through strong investigation, corrective and preventive action, and systemic improvement across products manufactured by and for the Business Unit.
• Report Quality System performance as the Management Representative to executive leadership through a structured and effective Management Review process, enabling data‑driven decision‑making and accountability.
• Act as a culture catalyst and talent multiplier by building a high‑performing, diverse, and future‑ready Quality organization through leadership development, succession planning, and continuous capability building.
• Foster collaboration, teamwork, and engagement across a large, global organization to strengthen end‑to‑end customer experience and business performance.
• Travel up to 30% and as required

Education and Experience:

• Minimum requirements are a BS degree or equivalent in a Pharmaceutical Science, Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred.
• Minimum of 15 years of experience in quality or regulatory affairs
• Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the non-regulated medical device industry e.g., ISO,
• Experienced in all regulatory compliance aspects of the business: pre-market, commercial, post
  market, and regulatory. Experience in instrumentation in either regulated or non regulated industry strongly preferred  
• Thorough knowledge of current quality management practices, and international regulations, design controls, manufacturing and servicing.

Knowledge and Skills:

• Demonstrated ability to build and sustain strong partnerships and alliances across a complex, global business environment, fostering collaboration and alignment across regions, functions, and stakeholders.
• Comprehensive expertise in the application and interpretation of global regulatory standards and requirements relevant to the medical device and pharmaceutical industries, including ISO,
• Strong knowledge of Cyber, Software and Safety Standards.
• Experience in divestiture and mergers. Proven ability to fulfill remediation efforts using a risk-based approach.
• Strong knowledge of pre‑market regulatory requirements, including regulatory submission and lifecycle management processes, design controls, and risk management.
• Proven ability to innovate and apply forward‑thinking approaches to Quality and Compliance within fast‑paced, evolving business environments.
• Exceptional written and verbal communication skills, with demonstrated strength in organization, project management, and influencing at senior levels.
• Capability to continuously assess the effectiveness of functional processes and lead progressive improvement initiatives using process excellence and continuous improvement methodologies.
• Strategic, “out‑of‑the‑box” thinker and change agent with the courage to challenge the status quo, lead transformation, and improve organizational performance.
• Leads courageously by taking personal ownership of critical issues, demonstrating sound judgment, ethical leadership, and the willingness to challenge decisions in the best interest of the organization and the customer/patient.
• Highly influential leader who presents compelling, well‑reasoned cases to gain stakeholder commitment and drive alignment around strategic initiatives.
• Applies insightful judgment by analyzing complex information, assessing and balancing risk, and making sound, timely decisions to solve business and quality challenges.
• Builds trust through principled leadership, transparency, and consistent demonstration of strong business ethics.
• Customer‑focused leader who works closely with internal and external customers to understand needs, translate requirements into effective solutions, and drive customer value.
• Execution‑oriented with a strong sense of urgency, effectively planning and delivering results while maintaining focus on quality and business outcomes.
• Committed to developing people and building strong organizational capability through talent identification, development, engagement, and succession planning.
• Demonstrates a strong global mindset by establishing and promoting effective Quality and Regulatory processes across multiple countries and regions, while coordinating effectively with the broader global enterprise.
• Prudent risk‑taker with the confidence to pursue opportunities, learn from experience, and make informed decisions that balance innovation, risk, and long‑term business sustainability.

Physical Demands: (if applicable)

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates.

Work Environment: (if applicable)

While performing the duties of this job, the employee may be in an open cubicle environment.  Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

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